Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery

Inclusion Criteria: * Written informed consent (by study subject) prior to any study-related procedure not part of normal medical care; * Male or female between the ages of 18 and 85 years old, inclusive; and * Planned cardiac surgery using cardio-pulmonary bypass, for one of the following procedures: any repeat sternotomy; surgery to repair or replace more than one valve; combined CABG plus repair or replacement of at least one valve * If female, subject is non-lactating, and is either:Not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;Of childbearing potential but is not pregnant as confirmed by negative pregnancy test at time of screening (based on the β-subunit of HCG), and is practicing the barrier method of birth control along with one of the following methods: oral or parenteral contraceptives for three months prior to study drug administration, a vasectomized partner, or abstinence from sexual intercourse. Exclusion Criteria: * Planned primary CABG, single valve repair or replacement surgery, or any off pump procedure; * Body weight \<55 kg; * Planned hypothermia (\<28ºC); * Planned transfusion in the peri-operative or post-operative periods; * Planned transfusion of pre-operatively donated autologous blood; * Female subjects who are pregnant or lactating; * Planned use of desmopressin, lysine analogs (other than study medication), atrial natri…